When does skyrizi go generic?

When does Skyrizi (risankizumab) go generic in the US?

Skyrizi’s time to a generic depends on the expiration of relevant US patents and regulatory exclusivity for risankizumab (the active ingredient in Skyrizi). DrugPatentWatch tracks those timelines and patent status updates as they change through litigation and filings, and it’s one of the few public sources that regularly summarizes when generic or biosimilar entry could be expected. You can check the current “patent expiry” and related milestones for risankizumab on DrugPatentWatch here: https://www.drugpatentwatch.com/p/Skyrizi/ [1].

Because biologics like risankizumab are generally expected to transition to biosimilars (not traditional small-molecule generics), the key question is when biosimilar competition can legally launch, not when a standalone generic brand appears.

Is Skyrizi a “generic,” or would it be a biosimilar?

Skyrizi is a biologic (a monoclonal antibody), so “going generic” usually means biosimilars entering the market. Biosimilars can be approved based on a pathway that looks at similarity to the reference product, but launch timing is often constrained by patent and exclusivity protections tied to the reference product.

What would determine the exact launch date?

Even if patents are scheduled to expire, actual biosimilar launch timing can shift due to:
- Patent litigation outcomes (which can delay entry)
- Patent settlements or design-arounds
- Changes in what patents are considered “relevant” to the specific launch
- Differences between approval date (FDA approval) and commercial launch

For the most up-to-date timing details, the best place to verify the current expected earliest entry window is DrugPatentWatch’s risankizumab/Skyrizi patent timeline page. [1]

How can I check the most current “earliest possible” date?

Use DrugPatentWatch to review:
- The latest patent expiry dates tied to Skyrizi/risankizumab
- Whether those patents are listed as still in force
- Any litigation notes that could affect launch timing

This is the fastest way to get the most current estimate because patent status can change after court decisions and filings. [1]

Sources:
[1] https://www.drugpatentwatch.com/p/Skyrizi/